Regulatory and Start Up Manager

3 days ago

Solna Municipality, Sweden IQVIA Full time

Job Overview

Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources.

Essential Functions

Oversee the execution of Site Activation (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines.

Develop, implement and maintain the Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required. Ensure collaboration across Regulatory & Site Activation, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan. Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required.

Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.

Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral member of the study management team.

Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations

Identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the site activation plan.

Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.

Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents.

Work with Quality Management to ensure appropriate quality standards for the duration of site activation (or Maintenance, as applicable).

Mentor and coach colleagues as required.

Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information.

May take a lead role in developing long standing relationships with preferred IQVIA customers.

Deliver presentations/training to clients, colleagues and professional bodies, as required. May be involved in activities related to monthly study budget planning and reviews.

Qualifications

Bachelor's Degree Life sciences or related field Req

7 years' relevant experience in a scientific or clinical environment including demonstrable experience in an international role. Equivalent combination of education, training and experience.

Strong negotiation and communication skills with ability to challenge

Excellent interpersonal skills and strong team player

Proven ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projects

Thorough understanding of regulated clinical trial environment and in-depth knowledge of drug development process

Demonstrated proficiency in using systems and technology to achieve work objectives

Good regulatory and/or technical writing skills

Strong knowledge and ability to apply Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelines

Good leadership skills, with ability to motivate, coach and mentor

Good organizational and planning skills

Ability to exercise independent judgment taking calculated risks when making decisions

Good presentation skills

Proven ability to establish and maintain effective working relationships with co-workers, managers and sponsors.

Excellent understanding of study financial management

Proven ability to work on multiple projects balancing competing priorities

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at

IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.

To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q2 Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.

EEO Minorities/Females/Protected Veterans/Disabled


  • Associate Manager, Clinical Trials Regulatory Management

    4 weeks ago

    Solna, Sweden IQVIA Full time

    Prepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for more complex projects. RESPONSIBILITIES Acts as a Clinical Trial Regulatory Manager (CTRM) on global projects which may be complex Ability to administratively and technically/scientifically review core scientific...

  • Manager, Clinical Operations

    2 weeks ago

    Solna Municipality, Sweden Cepheid Full time

    At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world's most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and...

  • Clinical Trial Assistant

    4 weeks ago

    Solna, Sweden IQVIA Full time

    Job Overview Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. Essential Functions • Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining...

  • Experienced CRA

    2 months ago

    Solna, Sweden IQVIA Full time

    Job Overview Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in...

  • Senior Regulatory Specialist

    2 weeks ago

    Leksand Municipality, Sweden Clas Ohlson Full time

    Ända sedan starten för mer än 100 år sedan har vi på Clas Ohlson haft en stark företagskultur som präglas av en vilja att göra kunden nöjd. Vi är lagspelare som bryr oss om varandra, våra kunder och resultatet av det vi gör, och vi har ett uttalat mål om att vara ledande inom hållbarhet. Om du delar vår ambition att hela tiden åstadkomma mer...

  • Clinical Program Manager

    2 weeks ago

    Solna Municipality, Sweden Cepheid Full time

    At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world's most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and...

  • Manager, Clinical Operations

    3 weeks ago

    Solna, Sweden Cepheid Full time

    At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and...

  • cloud & platform security specialist

    2 weeks ago

    Solna Municipality, Sweden SAS Cargo Group AS Full time

    Press Tab to Move to Skip to Content Link Select how often (in days) to receive an alert: CLOUD & PLATFORM SECURITY SPECIALIST City: Solna Job Function: IT About the TeamThe Cloud and Platform Team in SAS provides various capabilities to enable our product teams to build cloud-native solutions with great developer experience and provide them a platform...

  • cloud & platform security specialist

    2 weeks ago

    Solna Municipality, Sweden Huvudkontor Full time

    About the TeamThe Cloud and Platform Team in SAS provides various capabilities to enable our product teams to build cloud-native solutions with great developer experience and provide them a platform to innovate. We support our product teams who are organized in value streams with several products. The Cloud and Platform Team is segregated into several...

  • is Hiring: Digital Marketing Manager

    2 weeks ago

    Solna Municipality, Sweden Cellcolabs Full time

    Are you an experienced digital marketing superstar with a passion for healthcare and biotech? Cellcolabs, a cutting-edge biotech start-up, is seeking a dynamic Digital Marketing Manager to join our highly ambitious marketing/commercial team, playing a pivotal role in shaping our company's digital presence and driving international expansion.Cellcolabs is a...

  • Project Manager, Critical Care

    2 weeks ago

    Solna Municipality, Sweden Maquet Critical Care AB Full time

    At Getinge we have the passion to performJoin our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge, our passion is to secure that every person and community have access to the best possible care, offering hospitals and life science institutions products and solutions that aim to improve...

  • manager purchasing analyst

    2 weeks ago

    Solna Municipality, Sweden SAS Cargo Group AS Full time

    Press Tab to Move to Skip to Content Link Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Do you thrive in environments where no two days are the same? If so, don't miss the opportunity to join SAS strategic sourcing department as a Manager Purchasing Analytics and play a pivotal role delivering business...

  • Sr QA Scientist

    6 days ago

    Solna Municipality, Sweden Danaher Full time

    At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world's most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and...

  • Procurement Category Manager

    2 weeks ago

    Solna Municipality, Sweden Valueone AB Full time

    ValueOne is looking for a Procurement Category Manager with experience from strategic sourcing and category management for a consultant assignment at a company in Solna, north of Stockholm. The assignment starts in early August and lasts for six months with possibilities for extension.ValueOne are specialists in supply chain management, purchasing, and...

  • LTM 1 FTE Sweden fluent Norwegian

    4 weeks ago

    Solna, Sweden IQVIA Full time

    Clinical Trial Manager - This role requires Fluent Norwegian - Based in Sweden Global or Regional Applicability: Regional Trial Management services provide local management of a clinical trial (s) (or Medical Affairs data generation activity) in a country or countries. Services/deliverables include operational oversight of assigned project(s) at the...

  • Director Public Affairs Communications

    2 weeks ago

    Haninge Municipality, Sweden Coca Cola Full time

    Description Summary: The PACS director will perform the execution of the Europe overall strategic direction through local initiatives within the area of public affairs, sustainability and communications in the Swedish market. Key responsibilities include developing and executing 360 integrated communication plans and developing value-added relations with...

  • Director Public Affairs Communications

    2 weeks ago

    Haninge Municipality, Sweden The Coca-Cola Company Full time

    The PACS director will perform the execution of the Europe overall strategic direction through local initiatives within the area of public affairs, sustainability and communications in the Swedish market. Key responsibilities include developing and executing 360 integrated communication plans and developing value-added relations with media as well as other...

  • Business Area Manager

    2 weeks ago

    Solna Municipality, Sweden Orange Business Services Full time

    As aData & AI Business Area Manager at Orange Business, you will play a pivotal role in driving innovation and delivering cutting-edge data solutions to our clients. Your primary responsibility will be to build and develop the Data & AI business areafrom the ground up.You will be working directly with the local Managing Director and in close collaboration...

  • Global Product Safety Manager

    2 weeks ago

    Svedala Municipality, Sweden SANDVIK AB Full time

    Are you an inclusive leader always striving to move forward and improve people, processes and products? Then this might be the perfect opportunity for youAt Sandvik Rock Processing Solutions we're now looking for a Global Product Safety Manager for our Stationary Crushing and Screening Divisions. Welcome to a key role in ensuring the safety and compliance of...

  • Site Project Manager

    2 weeks ago

    Solna Municipality, Sweden Telia Company Full time

    We are seeking an experienced Site Project Manager to join our dynamic Deployment & Integration team in Telia. As a Site Project Manager, you will play a critical role in ensuring the successful acquisition of sites as well as the efficient execution of civil construction, contributing to the seamless deployment of our great mobile network. Your expertise...